Unique ID issued by UMIN | UMIN000004250 |
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Receipt number | R000005104 |
Scientific Title | Multicenter Study of Efficacy and Safety of recombinant thrombomodulin alfa for Obstetric disseminated intravascular coagulation (DIC) |
Date of disclosure of the study information | 2010/09/27 |
Last modified on | 2013/03/22 16:43:48 |
Multicenter Study of Efficacy and Safety of recombinant thrombomodulin alfa for Obstetric disseminated intravascular coagulation (DIC)
Multicenter Study of Efficacy and Safety of rTM for Obstetric DIC
Multicenter Study of Efficacy and Safety of recombinant thrombomodulin alfa for Obstetric disseminated intravascular coagulation (DIC)
Multicenter Study of Efficacy and Safety of rTM for Obstetric DIC
Japan |
Disseminated intravascular coagulation (DIC)
Obstetrics and Gynecology |
Others
NO
To investigate the efficacy and safety of rTM in patients with obstetric DIC.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Course of obstetric DIC score
Course of DIC score; Course of clinical symptom; Course of blood clotting test findings; Outcome of subjects; Transfusion; Blood loss; Adverse events; Adverse drug reaction
Observational
Not applicable |
Not applicable |
Female
1.Patients diagnosed clinically as DIC (the obstetrical DIC score reaches 8 points or more).
2.Postpartum or intrauterine fetal resuscitation.
3.Written informed consent of participation.
1.Patients showing intracranial, pulmonary or gastrointestinal hemorrhage.
2.Patients with a history of hypersensitivity to rTM.
3.Pregnant women, nursing mothers or possibly pregnant women (Fetal viability).
4.Hematopoetic malignancy.
5.Other patients judged to be inappropriate at the discretion of investigators.
50
1st name | |
Middle name | |
Last name | Masao Nakabayashi |
Maternal and Child Health Center Aiiku Hospital
Department of Obstetrics and Gynecology
5-6-8 Minami-Azabu, Minato-Ku, Tokyo 106-8580, Japan
03-3473-8321
1st name | |
Middle name | |
Last name |
Maternal and Child Health Center Aiiku Hospital
Department of Obstetrics and Gynecology
Maternal and Child Health Center Aiiku Hospital
None
Self funding
NO
順天堂大学医学部附属順天堂医院(東京都)
埼玉医科大学総合医療センター(埼玉県)
県西部浜松医療センター(静岡県)
宮崎大学医学部附属病院(宮崎県)
2010 | Year | 09 | Month | 27 | Day |
Unpublished
Completed
2010 | Year | 09 | Month | 16 | Day |
2010 | Year | 09 | Month | 01 | Day |
2013 | Year | 12 | Month | 31 | Day |
prospective observational study
2010 | Year | 09 | Month | 22 | Day |
2013 | Year | 03 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005104
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